Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004779
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase I Pilot Study of Ad5-CB-CFTR an Adenovirus Vector Containing the Cystic Fibrosis Transmembrane Conductance Regulator Gene in Patients With Cystic Fibrosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Assess the safety and efficacy of gene transfer into the nasal epithelium using Ad5-CB-CFTR an E1-deleted adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene in patients with cystic fibrosis CF
II Determine whether ion transport abnormalities in CF airway cells can be corrected
II Determine whether ion transport abnormalities in CF airway cells can be corrected
Detailed Description:
PROTOCOL OUTLINE
Groups of 3 patients receive 1 of 4 doses of Ad5-CB-CFTR a recombinant E1-deleted adenovirus serotype 5 vector containing the cystic fibrosis transmembrane conductance regulator gene Ad5-CB-CFTR is administered to 1 nasal cavity and the vehicle alone is administered to the opposite nasal cavity as the control
Groups of 3 patients receive 1 of 4 doses of Ad5-CB-CFTR a recombinant E1-deleted adenovirus serotype 5 vector containing the cystic fibrosis transmembrane conductance regulator gene Ad5-CB-CFTR is administered to 1 nasal cavity and the vehicle alone is administered to the opposite nasal cavity as the control
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-921 | None | None | None |